Brain and encephalography in epilepsy patient during a seizure. Credit: Kateryna Kon / Shutterstock.com.

The European Commission (EC) has approved Marinus Pharmaceuticals’ ZTALMY (ganaxolone) as an adjunctive treatment for epileptic seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in patients aged between two and 17 years.

Patients aged 18 years and older may continue with ZTALMY.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

ZTALMY oral suspension functions as a neuroactive steroid GABA [gamma-aminobutyric acid] receptor modulator, exhibiting its effects on a well-established brain target known for its anti-seizure properties.

The authorisation follows a positive opinion in May 2023 from the European Medicines Agency’s Committee for Medicinal Products for Human Use.

The approval applies to all 27 member states of the European Union and to Norway, Liechtenstein and Iceland.

The approval from the EC was based on data from the Phase III Marigold double-blind placebo-controlled study, which randomised and treated 101 patients with ZTALMY.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

The study attained its primary endpoint by demonstrating a median 30.7% reduction in 28-day major motor seizure frequency compared to a 6.9% median reduction for those receiving a placebo.

Marinus chairman and CEO Scott Braunstein stated: “The approval by the EC represents a significant milestone for children, families and physicians who, until now, have been challenged by the impact of seizures and lack of treatments available for CDD.

“This achievement reflects our organisation’s unwavering commitment to bringing an effective treatment option to individuals living with CDD and we are grateful to all the stakeholders who made the approval possible.”